Study to Investigate Hepatic Impairment on PK, Safety, Tolerability of Camizestrant in Post-Menopausal Female Subjects

Study identifier:D8532C00002

ClinicalTrials.gov identifier:NCT05790304

EudraCT identifier:N/A

CTIS identifier:2022-502277-41-00

Recruiting

Official Title

A Phase I, Single Dose, Non-Randomised, Multicentre, Open-Label, Parallel Group Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of Camizestrant in Post menopausal Female Subjects

Medical condition

Hepatic Impairment

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Camizestrant

Sex

Female

Estimated Enrollment

28

Study type

Interventional

Age

50 Years - 75 Years

Date

Study Start Date: 20 Feb 2023
Estimated Primary Completion Date: 22 Feb 2024
Estimated Study Completion Date: 22 Feb 2024

Study design

Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Other

Verification:

Verified 01 Jan 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria